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For any item to be covered by Medicare,
it must 1) be eligible for a defined Medicare benefit category, 2) be
reasonable and necessary for the diagnosis or treatment of illness or
injury or to improve the functioning of a malformed body member, and 3)
meet all other applicable Medicare statutory and regulatory requirements.
For the items addressed in this medical policy, the criteria for
"reasonable and necessary" are defined by the following
indications and limitations of coverage and/or medical necessity.
For an item to be covered by Medicare, a written signed and dated order
must be received by the supplier before a claim is submitted. If the
supplier bills for an item addressed in this policy without first receiving
the completed order, the item will be denied as not medically necessary.
INITIAL COVERAGE:
A single level continuous positive airway pressure (CPAP) device (E0601) is
covered for the treatment of obstructive sleep apnea (OSA) if criteria A -
C are met:
A.
The patient has a face-to-face clinical evaluation by the treating
physician prior to the sleep test to assess the patient for obstructive
sleep apnea.
For dates of service on or after September 1, 2008, the clinical
evaluation by the treating physician must include, at a minimum:
1.
Sleep history and symptoms including, but not limited to, snoring,
daytime sleepiness, observed apneas, choking or gasping during sleep,
morning headaches; and,
2.
Epworth Sleepiness Scale (See Appendices); and,
3.
Physical examination that documents body mass index, neck
circumference and a focused cardiopulmonary and upper airway system
evaluation.
B.
The patient has a Medicare-covered sleep test that meets either of
the following criteria (1 or 2):
1.
The apnea-hypopnea index (AHI) or
Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per
hour with a minimum of 30 events; or,
2.
The AHI or RDI greater than or equal to 5 and less than or equal to
14 events per hour with a minimum of 10 events and documentation of:
a.
Excessive daytime sleepiness, impaired cognition, mood disorders,
or insomnia; or,
b.
Hypertension, ischemic heart disease, or history of stroke.
C.
The patient and/or their caregiver has
received instruction from the supplier of the CPAP device and accessories
in the proper use and care of the equipment.
If a claim for a CPAP (E0601) is submitted and all of the criteria
above have not been met, it will be denied as not medically necessary.
Apnea is defined as the cessation of airflow for at least 10 seconds.
Hypopnea is defined as an abnormal respiratory
event lasting at least 10 seconds associated with at least a 30% reduction
in thoracoabdominal movement or airflow as
compared to baseline, and with at least a 4% decrease in oxygen saturation.
The apnea-hypopnea index (AHI) is defined as the
average number of episodes of apnea and hypopnea
per hour of sleep without the use of a positive airway pressure device.
The respiratory disturbance index (RDI) is defined as the average number of
apneas plus hypopneas per hour of recording
without the use of a positive airway pressure device.
If the AHI or RDI is calculated based on less than 2 hours of continuous
recorded sleep, the total number of recorded events used to calculate the
AHI must be at least the number of events that would have been required in
a 2 hour period (i.e., must reach ≥30 events without symptoms or
≥10 events with symptoms).
Respiratory Assist Devices (RAD)
A RAD without backup rate (E0470) is covered for those patients
with OSA who meet criteria A-C above, in addition to criterion D:
D.
A single level (E0601) positive airway pressure device has been
tried and proven ineffective, based on a
therapeutic trial conducted in either a facility or in a home setting.
If E0470 is billed and criterion D is not met, payment will be
based on the allowance for the least costly medically appropriate
alternative, E0601.
A RAD with backup rate (E0471) is not medically necessary if the
primary diagnosis is OSA; therefore, if E0471 is billed with a diagnosis of
OSA, the following payment rules apply:
1.
If criteria A - D above are met, payment will be based on the
allowance for the least costly medically appropriate alternative, E0470;
or,
2.
If criteria A-C above are met but not criterion D, payment will be
based on the allowance for the least costly medically appropriate
alternative, E0601.
If a CPAP device is tried and found
ineffective during the initial 3 month home trial, substitution of a RAD
does not require a new initial face-to-face clinical evaluation or a new
sleep test.
If a CPAP device has been used for more that 3 months and the patient is
switched to a RAD, a new initial face-to-face clinical evaluation is
required, but a new sleep test is not required. A new 3 month trial would
begin for use of the RAD.
Coverage, coding and documentation requirements for the use of RADs for diagnoses other than OSA are addressed in the
RAD policy.
Sleep Tests
Coverage and Payment rules for sleep tests may be found in the local
coverage determinations (LCDs) for the applicable Medicare Part A or Part B
contractor. There may be differences between those LCDs and the DME MAC
LCD. For the purposes of coverage of PAP therapy, the DME MAC coverage,
coding and payment rules take precedence.
Coverage of a PAP device for the treatment of OSA is limited to claims
where the diagnosis of OSA is based upon a Medicare-covered sleep test
(Type I, II, III, IV or Watch-PAT 100). A Medicare-covered sleep test must
be either a polysomnogram performed in a
facility-based laboratory (Type I study) or a home sleep test (HST) (Types
II, III, IV, or Watch-PAT 100). The test must be ordered by the
beneficiary’s treating physician and conducted by an entity that qualifies
as a Medicare provider of sleep tests and is in compliance with all
applicable state regulatory requirements.
A Type I sleep test is the continuous and simultaneous monitoring and
recording of various physiological and pathophysiological
parameters of sleep with physician review, interpretation, and report. It
is facility-based and must include sleep staging, which is defined to
include a 1-4 lead electroencephalogram (EEG), and electro-oculogram (EOG), submental electromyogram (EMG) and electrocardiogram (ECG). It
must also include at least the following additional parameters of sleep:
airflow, respiratory effort, and oxygen saturation by oximetry.
It may be performed as either a whole night study for diagnosis only or as
a split night study to diagnose and initially evaluate treatment.
An HST is performed unattended in the beneficiary’s home using a portable
monitoring device. A portable monitoring device for conducting an HST must
meet one of the following criteria:
A.
Type II device – Monitors and records a minimum of seven (7)
channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and
oxygen saturation; or,
B.
Type III device – Monitors and records a minimum of four (4)
channels: 2 respiratory movement/airflow, ECG/heart rate and oxygen
saturation; or,
C.
Type IV device – Monitors and records a minimum of three (3)
channels that must include respiratory effort, airflow and oxygen
saturation.
D.
Watch-PAT100 (Itamar Medical)
Watch-PAT100 does not measure airflow;
therefore, the RDI or AHI derived does not meet the previously listed
definitions for apnea or hypopnea. However,
Watch-PAT 100 is considered a Medicare-covered HST for the purposes of this
policy and the RDI derived must meet the threshold values listed in
criterion B above for coverage.
For dates of service on or after September 1, 2008, all beneficiaries who
undergo a HST must, prior to having the test, receive a face-to-face
demonstration of how to properly apply a portable sleep monitoring device.
This education must be provided by the entity conducting the HST and may
not be performed by a DME supplier.
For dates of service on or after September 1, 2008, all sleep tests must be
interpreted by a physician who is either:
- A diplomat of
the American Board of Sleep Medicine (ABSM); or,
- Diplomat in
Sleep Medicine by a member board of the American Board of Medical
Specialties (ABMS); or,
- An active
staff member of a sleep center or laboratory accredited by the American Academy of Sleep Medicine
(AASM) or The Joint Commission (formerly the Joint Commission on
Accreditation of Healthcare Organizations – JCAHO).
No aspect of an HST, including but not
limited to delivery and/or pickup of the device, may be performed by a DME
supplier. This prohibition does not extend to the results of studies
conducted by hospitals certified to do such tests.
CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:
Continued coverage of a PAP device (E0470 or E0601) beyond the first three
months of therapy requires that, no sooner than the 61st day but no later
than the 91st day after initiating therapy, the treating physician must
conduct a clinical re-evaluation and document that the beneficiary is
benefiting from PAP therapy.
For dates of service on or after September 1, 2008, documentation of
clinical benefit is demonstrated by:
- Face-to-face
clinical re-evaluation by the treating physician with documentation
that symptoms of obstructive sleep apnea are improved; and,
- Objective evidence of adherence
to use of the PAP device.
Adherence to therapy is defined as use of PAP ≥ 4 hours per
night on 70% of nights during a consecutive thirty (30) day period anytime
during the first three (3) months of initial usage.
If the above criteria are not met, continued coverage of a PAP device and
related accessories will be denied as not medically necessary.
If the physician re-evaluation does not occur until after the 91st day but
the evaluation demonstrates that the patient is benefiting from PAP therapy
as defined in criteria 1 and 2 above, continued coverage of the PAP device
will commence with the date of that re-evaluation.
If a CPAP device is tried and found ineffective during the initial 3 month
home trial, substitution of a RAD (E0470) does not change the length of the
trial. The clinical re-evaluation would occur between the 61st and 91st day
following the initiation of CPAP.
If a CPAP device was used for more that 3 months and the patient was
switched to a RAD, then the clinical re-evaluation would occur between the
61st and 91st day following the initiation of the RAD. There would also
need to be documentation of adherence to therapy during the 3 month trial
with the RAD.
If there is discontinuation of usage of a PAP device at any time, the
supplier is expected to ascertain this and stop billing for the equipment
and related accessories and supplies.
For a PAP device dispensed prior to September 1, 2008, if the initial
coverage criteria in effect at the time were met and the criteria for
coverage after the first 3 months that were in effect at the time were met,
the device will continue to be covered for dates of service on or after
September 1, 2008 as long as the patient continues to compliantly use the
device.
ACCESSORIES:
Accessories used with a PAP device are covered when the coverage criteria
for the device are met. If the coverage criteria are not met, the
accessories will be denied as not medically necessary.
The following table represents the usual maximum amount of accessories
expected to be medically necessary:
A4604 - 1 per 3 months
A7027 - 1 per 3 months
A7028 - 2 per 1 month
A7029 - 2 per 1 month
A7030 - 1 per 3 months
A7031 - 1 per 1 month
A7032 - 2 per 1 month
A7033 - 2 per 1 month
A7034 - 1 per 3 months
A7035 - 1 per 6 months
A7036 - 1 per 6 months
A7037 - 1 per 3 months
A7038 - 2 per 1 month
A7039 - 1 per 6 months
A7046 - 1 per 6 months
Quantities of supplies greater than those described in the policy as the
usual maximum amounts will be denied as not medically necessary.
Either a non-heated (E0561) or heated (E0562) humidifier is covered when
ordered by the treating physician for use with a covered PAP (E0470 or
E0601) device.
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